Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0785-2024 — iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3325, h) C10684

U.S. FDA — Device Enforcement · United States · 2023-12-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0785-2024
Date of alert
2023-12-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Beckman Coulter, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10837461001188
Reported risk: Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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